An interventional study of IOL implantation experimental in Cataract, Lens Opacities and Presbyopia, sponsored by Beaver-Visitec International, Inc.. Active, not recruiting at 1 site in Philippines. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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Among 36 studies in Cataract by Beaver-Visitec International, Inc. — none open to participants now, 2 under way, none of them phase 3. Cataract · Beaver-Visitec International, Inc..
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., this one is the 7th largest by planned enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2019, is one of 28 with no phase, and was the 13th registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 36 studies in Cataract by Beaver-Visitec International, Inc. is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2019.
This study's planned enrollment of 100 is above the median of 79 across 1,094 interventional studies indexed under Cataract.
Median enrollment 53 across the 28 interventional studies, 62 across the 8 observational. Of the 32 that completed or were terminated, 2 (6%) have results posted.
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Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425)
This is a prospective, controlled, single-surgeon, single-center clinical study, whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. The study is aimed to compare visual acuity outcomes the FineVision POD FT IOL to data obtained in a similar study by the same principal investigator on the trifocal FineVision POD F IOL (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425), whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the FineVision POD FT IOL in both eyes or, in case the corneal astigmatism in one of the two eyes of the same patient is too small to implant a toric lens, the FineVision POD F IOL will be implanted in this eye (both lenses: PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD FT and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is that that the POD FT IOL is the toric version of the POD F IOL. The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 11 study visits (1 preoperative, 2 operative and 8 postoperative) over a period of 24 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 6 months follow up visit and secondary endpoint data will be collected at the 1 Day, 1 Week, 1 month, 6, 12 and 24 months postoperative visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.
Device: IOL implantation experimental
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. If both eyes of the same patient qualify for the implantation of a trifocal toric lens, a bilateral implantation will be performed. If only one eye qualifies for a trifocal toric lens, the contralateral eye will be implanted with the spherical trifocal IOL POD F (both lenses: (PhysIOL, Liège, Belgium).
Also known as: POD FT IOL implantation
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
Monocular visual acuity outcomes on CDVA under photopic light conditions are statistically non-inferior to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425).
Time frame: 6 months (120-180 days) postoperative
Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Pupil Size
Photopic and mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: 6 months postoperative
Uncorrected Distance Visual Acuity (UDVA) - monocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Uncorrected Distance Visual Acuity (UDVA) - binocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Corrected Distance Visual Acuity (CDVA) - monocular
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Corrected Distance Visual Acuity (CDVA) - binocular
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular mesopic.
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Time frame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) - binocular
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Time frame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular mesopic
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed binocularly.
Time frame: 6 months postoperative
Binocular Contrast Sensitivity under photopic light conditions
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Binocular Contrast Sensitivity under mesopic light conditions
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 6 months postoperative, 12 months postoperative, 24 months postoperative
Patient reported outcomes
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire Quality of Vision (QoV) und Near Activity Visual Questionnaire (NAVQ) will be used.
Time frame: 6 months postoperative, 12 months postoperative
Slitlamp examination - Corneal Status
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal Status
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Fundus examination with dilated pupil
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus
Time frame: Pre-OP, 1 month postoperative, 12 months postoperative
Slitlamp examination - Signs of inflammation
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: * Signs of inflammation * Anterior chamber cells, * Anterior chamber flare, * Cystoid macular oedema, * Hypopyon, and * Endophthalmitis
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - Pupillary block
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Pupillary block
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - Retinal detachment
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Retinal detachment
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - Status of anterior and posterior capsule
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Status of anterior and posterior capsule
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - IOL decentration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL decentration
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - IOL tilt
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL tilt
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - IOL discoloration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL discoloration
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - IOL opacity
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL opacity
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Photograph of IOL with dilated pupil to asses IOL rotation
This examination shall only be performed in eyes implanted with POD FT lenses. To determine the rotational stability of the toric lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or other technique in order to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp. To determine the rotational stability it is important that the IOL axis marks of the toric IOL are visible as well concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks.
Time frame: OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Intraocular pressure (IOP) measurement
The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Keratometry
Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: Pre-OP
Biometry
Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: Pre-OP
IOL power and target refraction
The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: Operative (day of Surgery)
Fundus OCT
An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time frame: Pre-OP
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Sep 2026, 89 months after the start.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 89 months is above that.
Counting every sponsor, half of 493 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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